A variety of vessels, devices, components and unit operations for manipulating liquids and/or for carrying out chemical, biochemical and/or biological processes are available. For instance, biological materials (e.g., animal and plant cells) including, for example, mammalian, plant or insect cells and microbial cultures can be processed using bioreactors. Manufacturing of complex biological products such as proteins (e.g., including monoclonal antibodies, peptides, and hormones) require multiple steps ranging from fermentation or cell culture (bacteria, yeast, insect or fungi), to primary recovery, and finally, to purification. Conventional manufacturing of biotechnology products is generally accomplished using batch or fed-batch processing through a series of unit operations with subsequent off-line laboratory analysis conducted on representative samples collected from various points of the process to ensure quality.
In some cases, increased efficiency may be achieved using continuous bioprocessing compared to batch or fed-batch operations. The increased efficiency can stem from reduced loss of production time to equipment turnaround and smaller, more productive machinery. In operations such as certain bioreactions, fresh cell culture media may be pumped into and out of the bioreactor continuously, maintaining a constant volume of culture in the reactor. Furthermore, cell retention in the bioreactor or cell recycle from the harvest stream out of the bioreactor can be performed such that cells are not lost via product removal from the bioreactor. This maintenance of high cell density in the bioreactor can improve production rates of the bioreaction compared to batch systems.
Although manufacturing systems such as chemical manufacturing systems, pharmaceutical manufacturing systems, and bioreactor systems are known, improvements to such systems would be useful in a variety of fields. In particular, as recognized by the present inventors in the context of the present invention, systems which include disposable components specially configured for performing continuous perfusion would be beneficial.